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海正藥業(600267.SH):獲特治星藥品補充申請批件
格隆匯 01-21 22:08

格隆匯1月21日丨海正藥業(600267.SH)公佈,近日,公司控股子公司瀚暉製藥有限公司(以下簡稱“瀚暉製藥”)收到國家藥品監督管理局核准簽發的關於注射用哌拉西林鈉他唑巴坦鈉(商品名“特治星”)的《藥品補充申請批件》。

特治星為國內上市的原研藥品,適用於治療由下列病症中指定細菌的易感分離株引起的中度至重度感染:1.社區獲得性肺炎;2.醫院獲得性肺炎;3.泌尿道感染;4.腔內感染;5.皮膚及軟組織感染;6.細菌性敗血症;7子宮內膜炎或盆腔炎;8.骨與關節感染;9.多種細菌混合感染。

經查詢IMS數據庫,特治星(4.5g,同規格)2018年全球銷售額為9.62億美元,其中中國銷售額為1.32億美元;2019年1-9月全球銷售額為7.54億美元,其中中國銷售額為1.22億美元。

瀚暉製藥產品特治星在中國國內分包裝的申請於2019年12月26日被國家藥監局受理,並於2020年1月13日獲得批准,後續待包裝工藝驗證和GMP生產現場核查後,方可實現商業化生產及銷售。為最終實現特治星的完全地產化轉移,該藥品研發項目累計已投入約150萬元人民幣。

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